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NCT Number: NCT06849622

Auto-antibody Dosage From Blood Spots for Diagnosis of Type 1 Diabetes and Celiace Disease

Early diagnosis of type 1 diabetes and celiac disease is very useful, allows early therapy and prevents deaths from the onset of diabetic ketoacidosis. This is a pilot study on screening of autoantibodies of type 1 diabetes and celiac disease in tuscany patients. The study aims to evaluate the concordance between the screening results obtained using two different matrix (blood drop spots on card and serum) in the search for autoantibodies for celiac disease and for type 1 diabetes. Moreover, it will be evaluated the feasibility and acceptability of the screening on a sample of the population enrolled in the territory through the participation of pediatricians.

Recruiting

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Key information

Conditions

Celiac Disease in Children Autoimmune Diseases Diabetes Mellitus Diabetes Mellitus, Type 1 Diabetes Mellitus, Type I Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases Screening

Age range

2 year–13 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Meyer Children's Hospital IRCCS

Florence, Italy, 50139

Location status: Recruiting

Location contact

Chiara Azzari

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients aged 2-13 years
  • Patients with a confirmed diagnosis of type 1 diabetes or celiac disease (positive controls) and children who do not have type 1 diabetes or celiac disease or autoantibodies associated with these pathologies (controls)
  • Obtained informed consent

Exclusion criteria

  • none

Treatment and study plan

Test on blood sample

Diagnostic Test

The blood sample will be drawn by venipuncture during clinical routine. The serum will be tested for coeliac or diabetes 1 auto-antibodies, using Elisa test.

Test on dried blood sample

Diagnostic Test

A finger prick will be used to collect Dried blood Spot (DBS) on a special card. The eluted blood spot will be tested, for coeliac and diabetes 1 auto-antibodies, using the same method used for serum, and the same cut-offs for positivity and negativity (Elisa tests)

Primary outcomes

  1. Comparability between spot and serum tests of the following parameters tissue transglutaminase Immunoglobuline A (tTg IgA) test, reference values <16 Units/ml

    Time frame: Baseline

Secondary outcomes

  1. Comparability between spot and serum tests of the following parameters: anti-insulin antibodies (IAA) test, reference values <10 Units/ml

    Time frame: Baseline

  2. Comparability between spot and serum tests of the following parameters: protein tyrosine phosphatase antibodies (IA2) test, reference values <7.5 Units/ml

    Time frame: Baseline

  3. Comparability between spot and serum tests of the following parameter glutamic acid decarboxylase antibodies (GAD-65) test, reference values <5.5Units/ml

    Time frame: Baseline

  4. Comparability between spot and serum tests of the following parameter zinc transporter 8 (ZnT8) test, reference values <15Units/ml

    Time frame: Baseline

  5. Antibody titers (Units/ml) for coeliac disease autoantibodies and type 1 diabetes

    Time frame: Baseline

Study contacts

Contact information is provided by the study sponsor or research team.

Chiara Azzari

CONTACT

[email protected]

+3905556621

Sponsors and collaborators

Lead sponsor

Meyer Children's Hospital IRCCS

Other

Registry information

Acronym: CELDI

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Feb 27, 2025
Registry last updated
Feb 27, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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